VA patients with serious mental illnesses (SMI- e.g., schizophrenia, bipolar disorder) die an average of 13-18 years earlier compared to the general U.S. population, mostly from cardiovascular disease (CVD). Increased risk of CVD and related risk factors in persons with SMI are attributable to unhealthy lifestyles exacerbated by mental health-related symptoms, medication side effects (e.g., weight gain), and the fragmentation of physical and mental health services.
The objectives of this study were to adapt and test the feasibility of an evidence-based psychosocial intervention (Life Goals Collaborative Care- or LGCC) designed to promote health behavioral change and reduce CVD risk factors among VA patients with SMI in order to inform a larger implementation study across different VHA settings.
This pilot randomized controlled study involved patients with SMI and CVD risk were randomized to receive LGCC or enhanced treatment as usual (eTAU). The enrollment process was designed to maximize generalizability of participants for future implementation studies and involved phone-based screening and recruitment. Patients with SMI (schizophrenia, bipolar disorder, or major depression diagnosis) seen at the VA Ann Arbor mental health clinic were initially screened for eligibility based available data on mental health and CVD risk factor diagnoses (diabetes, hypertension, hyperlipidemia, or BMI >25) using CPRS. Potentially eligible patients were sent letters explaining the study, with the option to not be contacted. Patients were then contacted by phone and once eligibility was confirmed they were consented and scheduled for a baseline survey and randomization. After obtaining informed consent, patients were randomized to LGCC or enhanced treatment as usual (eTAU, which included mailings on wellness topics in addition to standard care). LGCC is a manual-based intervention that incorporates behavioral change strategies within a Chronic Care Model-based program. It is designed to reduce risk factors for CVD through improved control of psychiatric symptoms and increased positive health behaviors, as well as improved coordination of physical and mental health care. LGCC consists of 1) 10 sessions focused on CVD risk reduction through behavioral change within the context of patients' psychiatric symptoms; 2) participant goal setting in diet and exercise; 3) customized ongoing motivational interviewing (MI)-based patient contacts with a health specialist for 6 months, in addition to 4) strategies to increase provider access and support for behavioral change and medical management. Primary (12-month) outcomes included CVD risk factors (blood pressure, BMI, cholesterol) ascertained from clinical assessments, as well as functioning, mental and physical health-related quality of life, and mental health symptoms ascertained from a patient self-completed survey. Additional administrator, consumer and provider interviews were conducted determine feasibility and acceptance of LGCC in routine practice were also completed.
Thirty patients participated in this initial pilot of LGCC. The mean age was 55, 15% women, and 12% African-American, reflecting similar demographic characteristics of the Ann Arbor mental health clinic population. Forty percent were diagnosed with schizophrenia, 27% with major depressive disorder, and 32% with bipolar disorder, with the majority (59%) having >=3 CVD risk factors. Of the 14 randomized to LGCC, the average number of sessions completed was 8. Compared to eTAU, LGCC was associated with clinically significant changes in systolic blood pressure (D=.22) and high-density lipoprotein levels (D=0.39) within a 12-month period, two major risk factors for CVD based on Framingham criteria. LGCC compared to eTAU was also associated with moderate effects in depressive symptom reduction (D=.27).
This study is addressing VA HSR&D research priorities related to mental health and care of complex, chronic conditions, and is consistent with the priorities of the VHA's Office of Mental Health Services (Patient Care Services), 10NC, and the National Center for Health Promotion and Disease Prevention. Serious mental illness (SMI) is associated with significant disability, decreased quality of life, and a decreased life span. The VA is undergoing three major quality improvement initiatives: the Patient-Aligned Care Team (PACT), which involves enhanced access and continuity of care based on Chronic Care Model (CCM) principles, as well as dissemination of Health Behavior Coordinators and Psychosocial Rehabilitation and Recovery Centers that incorporate similar self-management principles. However, to date these programs have not been fully integrated to address gaps in quality or outcomes of care for Veterans with SMI, and could potentially benefit from a common manual-based program such as LGCC.
- Kilbourne AM, Bramlet M, Barbaresso MM, Nord KM, Goodrich DE, Lai Z, Post EP, Almirall D, Verchinina L, Duffy SA, Bauer MS. SMI life goals: description of a randomized trial of a collaborative care model to improve outcomes for persons with serious mental illness. Contemporary clinical trials. 2014 Sep 1; 39(1):74-85.
- Kilbourne AM. Multisite Randomized Controlled Trial of Life Goals Collaborative Care to Reduce CVD Risk in Patients with Serious Mental Illness. Paper presented at: VA HSR&D / QUERI National Meeting; 2012 Jul 19; National Harbor, MD.
- Kilbourne AM. Implementing Behavioral Interventions for Mood Disorders. Paper presented at: Shaping the Research Agenda for Depression Prevention Conference; 2011 Sep 12; Long Beach, CA.